Primary Immunodeficiency Diseases (PID)NCT06565078
A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
An observational study of Primary Immunodeficiency Diseases (PID), run by Takeda at 1 site in Japan.
Trial summary
This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Immunodeficiency Diseases (PID)
- What is being tested?
- Immune Globulin Subcutaneous (Human), 20% Solution
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 17 Feb 2025to 31 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.
Who may be able to join
- Patients with primary immunodeficiency (PID) enrolled in the PID patient registry.
- Participant for whom study drug is entered in the therapeutic drug field on the data set.
- Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
- Participant for whom the presence or absence of adverse events has been entered in the column of adverse events.
Who cannot join
- Participant for whom study drug has not been entered in the drug name in the medical history field during the period from January 24, 2024 to January 23, 2029.
- Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
- Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Study Director contact
About this study
Official title: Post-marketing Database Survey: A Cohort Study to Evaluate the Safety of Cuvitru in Patients With Primary Immunodeficiency Using the PIDJ2 (Primary Immunodeficiency Database in Japan) Registry
This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2.
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Being tested
- Immune Globulin Subcutaneous (Human), 20% Solution
- Keywords
- Primary immunodeficiency disease
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin Subcutaneous (Human), 20% SolutionDrug
CUVITRU 20% Solution
| Study group | Role | What they receive |
|---|---|---|
| Immune Globulin Subcutaneous (Human), 20% Solution | Participants with primary immunodeficiency disease who received Immune Globulin Subcutaneous (Human) 20% infusion in accordance with package insert. Receives: Drug: Immune Globulin Subcutaneous (Human), 20% Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience anaphylactic reaction as an AE will be reported.
Measured: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
Number of Participants Who Experience Thromboembolism as an AE
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience thromboembolism as an AE will be reported.
Measured: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
Number of Participants Who Experience Aseptic Meningitis as an AE
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience aseptic meningitis as an AE will be reported.
Measured: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start17 Feb 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency Diseases (PID)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565078
- Sponsor's protocol ID
- SHP664-403
- Other IDs
- jRCT2031240293
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Database Survey: A Cohort Study to Evaluate the Safety of Cuvitru in Patients With Primary Immunodeficiency Using the PIDJ2 (Primary Immunodeficiency Database in Japan) Registry
- ClinicalTrials.gov ID
- NCT06565078
- Acronym / sponsor ID
- SHP664-403
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Keywords
- Primary immunodeficiency disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immune Globulin Subcutaneous (Human), 20% Solution | – | Drug: Immune Globulin Subcutaneous (Human), 20% SolutionParticipants with primary immunodeficiency disease who received Immune Globulin Subcutaneous (Human) 20% infusion in accordance with package insert. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of this survey are all participants who meet the inclusion/exclusion criteria.
Key inclusion criteria (4 listed)
- Patients with primary immunodeficiency (PID) enrolled in the PID patient registry.
- Participant for whom study drug is entered in the therapeutic drug field on the data set.
- Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
- Participant for whom the presence or absence of adverse events has been entered in the column of adverse events.
Key exclusion criteria (3 listed)
- Participant for whom study drug has not been entered in the drug name in the medical history field during the period from January 24, 2024 to January 23, 2029.
- Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
- Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune Globulin Subcutaneous (Human), 20% SolutionCUVITRU 20% Solution | Drug | Immune Globulin Subcutaneous (Human), 20% Solution |
Primary outcome
Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)
Time frame: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience anaphylactic reaction as an AE will be reported.
Number of Participants Who Experience Thromboembolism as an AE
Time frame: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience thromboembolism as an AE will be reported.
Number of Participants Who Experience Aseptic Meningitis as an AE
Time frame: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience aseptic meningitis as an AE will be reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immunodeficiency Diseases (PID), run by Takeda at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE) (time frame: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.